Full Text View
Tabular View
No Study Results Posted
Related Studies
Viagra for the Treatment of IUGR
This study is not yet open for participant recruitment.
Verified by Rambam Health Care Campus, June 2006
First Received: July 3, 2006   No Changes Posted
Sponsor: Rambam Health Care Campus
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00347867
  Purpose

It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that normally inhibits blood vessels’ ability to expand) may have beneficial effects in hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed without any reduction in maternal blood pressure, thereby dissociating hypertension per se from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following publications, suggesting that sildenafil citrate used as a therapeutic agent may improve myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation, decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend to administer this medication to parturients where intauterine growth restriction and pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation and improved uteroplacental perfusion resulting in improved fetal growth.


Condition Intervention Phase
IUGR
Drug: Viagra administration in IUGR/PET pregnancies
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Improvement of Utero-Placental Perfusion and Fetal Growth in IUGR and PET by Administration of Sildenafil Citrate in Pregnancy

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Uteroplacental perfusion
  • Fetal growth
  • Maternal and fetal safety

Estimated Enrollment: 20
Study Start Date: July 2006
Detailed Description:

Each participant will receive, after informed consent a 25 mg tablet of Viagra [sildenafil citrate ]orally. The uteroplacental perfusion will be measured using transvaginal and transabdominal ultrasound Doppler velocimetry studies, before and after 2, 4, and 24 hours of Viagra ingestion. If no significant side effects are recorded, the protocol will be repeated , 48 hours after the first tablet ingestion, but using 50 mg Viagra.In cases of positive and encouraging results and if no serious side effects are detected we shall consider repeated administration of the lowest effcetive dose of viagra in an attempt to prevent prematurity and possibly reach term.our study will evaluate the effects of Viagra on uterine blood flow changes during pregnancy, and possible changes in other systems that contribute to normal fetal growth and development, in parallel to monitoring general and possible deleterious effects on the retina or other possible maternal or fetal organs.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • IUGR/PET/Pregnancy weeks 24-33.
  • Informed consent.

Exclusion Criteria:

  • Maternal cardiovascular morbidity.
  • Usage of any vasodilator medication
  • Smoking
  • Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347867

Contacts
Contact: Zeev Blumenfeld, MD 972-4-8542577 z_blumenfeld@rambam.health.gov.il

Locations
Israel
RAMBAM Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Zeev Blumenfeld, MD RAMBAM Health Care Campus, Technion
  More Information

No publications provided

Study ID Numbers: Viagra.CTIL
Study First Received: July 3, 2006
Last Updated: July 3, 2006
ClinicalTrials.gov Identifier: NCT00347867     History of Changes
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
IUGR
PET
Pregnancy
Viagra
Sildenafil citrate

Additional relevant MeSH terms:
Vasodilator Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Fetal Diseases
Pathologic Processes
Phosphodiesterase Inhibitors
Therapeutic Uses
Growth Disorders
Fetal Growth Retardation

ClinicalTrials.gov processed this record on November 30, 2009